Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 07/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1, 3-7, 9-12, 20, 22, 34, 43-45, 54, 56 and 58 are pending, claims 1, 3-7 and 9-10 are under examination.
Claim Objection
Claim 10 is objected for depending on rejected claim 1.
Claim Rejections - 35 USC § 112
Improper Markush Rejection
Claims 1, 3-7 and 9 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1, 3-7 and 9 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: although a compound of formula (I) share a core structure of MeO-C6H4-C(=O)-NH-L1-N, the compound of formula (I) are not considered to share a “single structural similarity” because the significant structure difference of those substituent such as L1 (alkyl or cyclo or aryl, etc), R2a, R2b , R2c and R2d (alkyl, heterocylcoalkyl, etc). Thus, the core structure MeO-C6H4-C(=O)-NH-L1-N is not considered as substantial structural feature of compound of formula (I). Furthermore, only those compounds cited in claim 10 have been prepared and tested as lipid for drug delivery, no structure and activity relationship has been established for the whole scope of a compound of formula (I) regarding the lipid delivery of drug. Thus, the compound of formula (I) has not shared common use. In summary, the compound of formula (I) is not considered to share a “single structural similarity” and common use, and this is improper Markush grouping of alternatives
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3-4 recites L1 is selected from four substituents with R6 is H, substituted C1-C24 alkyl, CH3, CH2CH(OH) and ---L2-N(R2c)R2d, when R6 is H, substituted C1-C24 alkyl, CH3 or CH2CH(OH), L1 does not have ---L2-N(R2c)R2d. Thus, claims 3-4 fails to include all the limitations of claim 1 (requires ---L2-N(R2c)R2d in L1) which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Argument:
Applicants argue that after amendment there is a “single structural similarity” and a common use. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. As discussed in the above improper Markush rejection, the significant structure difference of those substituent such as L1 (alkyl or cyclo or aryl, etc), R2a, R2b , R2c and R2d (alkyl, heterocylcoalkyl, etc). Thus, the core structure MeO-C6H4-C(=O)-NH-L1-N is not considered as substantial structural feature of compound of formula (I). Furthermore, only those compounds cited in claim 10 have been prepared and tested as lipid for drug delivery, no structure and activity relationship has been established for the whole scope of a compound of formula (I) regarding the lipid delivery of drug. Thus, the compound of formula (I) has not shared common use. In summary, the compound of formula (I) is not considered to share a “single structural similarity” and common use, and this is improper Markush grouping of alternatives. Therefore, the improper Markush rejection is still proper.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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